why is human research ethics review necessary
to protect
- research participants
- researchers
- society
research ethics pertains to
- how research questions framed
- how participants recruited
- disclosure of purpose and risks/benefits
- consent….
- privacy and confidentiality
- conflicts of interest
key tensions in research ethics
- balancing (individual rights vs public benefit, inclusion vs exploitation, scientific imperatives with research ethics)
- international settings
- standards challenged by new practises and technologies
field of reflection
examine relationship between researchers and research participants
field of intervention
- regulating and supervising research activity by defining deontological standards…..
two basic concepts of the Richtlinien
- protect subjects and patients
- encouraging new therapy and human experimentation
Nuremberg code
- consent and right of withdrawal
- social relevance of the research and its scientificity
- avoid unnecessary suffering
- prohibition of studies where death or great injury will occur
- risk must not exceed humanitarian importance of the problem
- researcher must be prepared to stop the research
key element of Nuremberg
voluntary consent of human subject is absolutely essential
the TCPS is a joint research ethics policy statement of
CIHR, NSERC, SSHRC
Principles of TCPS2
- respect for persons
(consent) - concern for welfare
- justice
consent
must be
1. voluntary
2. informed
3. ongoing
what is a REB
- ensures highest ethical standards with research involving human participants
what is a REB composed of
2 expertise in science
1 expertise in ethics
1 interest in a non-scientific field
1 community member
when is an REB brought in
- research with human remains, tissues, fluid, embryos
- interviews, surveys, questionnaires
- certain secondary analysis of data from living persons
principle of minimal risk
- magnitude of possible harms no greater than everyday life
what is exempt from REB
- existing data in public domain
- observation in public places
- studies internal to an organization
- secondary use of anonymized data
8 research principles
- social value
- scientific validity
- fair subject selection
- favourable risk-benefit ratio
- independent review
- informed consent
- respect for human subjects
- collaborative partnership
